Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema

Phase 4

Completed

• Conditions: Acute Cardiogenic Pulmonary Edema
• Interventions: Device: CPAP; Device: BIPAP; Other: standard therapy (ST)

• Registration Number: NCT00912158
• Lead Sponsor: Assiut University

Brief Summary

Cardiogenic pulmonary edema (CPE) is a common medical emergency and noninvasive ventilation (NIV) in addition to conventional medical treatment might be beneficial for patients with CPE.

Detailed Description

To evaluate the effect of adding continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) to standard medical therapy (ST) on intensive care unit (ICU) stay, hospital stay, mortality, need for endotracheal intubation, partial arterial O2 tension (PaO2), intrapulmonary shunt, alveolar-arterial (A-a) oxygen gradient, and cardiac output in patients admitted to the respiratory intensive care unit (ICU) or cardiac care unit (CCU) with acute CPE with gas exchange abnormalities and to evaluate the impact of heart failure type on the outcome of different therapeutic schedules.

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Study First Submitted: 2009-04-08
• Results First Submitted: 2009-04-08
• Study First Submitted QC: 2009-04-09
• Results First Submitted QC: 2009-04-09
• Study First Posted: 2009-06-03
• Results First Posted: 2009-06-03
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-17
• Last Update Posted: 2009-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

1. CPE confirmed radiologically and/or clinically
2. Severe acute respiratory failure (partial arterial oxygen (PaO2)/Fraction of inspired oxygen (FIO2) less than 250)
3. Dyspnea of sudden onset with respiratory
4. Systolic blood pressure < 180 mmHg

Exclusion Criteria

1. Immediate need for endotracheal intubation:

   • Severe sensorial impairment
   • Shock
   • Ventricular arrhythmias,
   • Life-threatening hypoxia (SpO2 [oxygen saturation as indicated by pulse oximetry] less than 80% with oxygen)
   • Acute myocardial infarction necessitating thrombolysis
   • Cardiac or respiratory arrest

2. Severe chronic renal failure

3. Pneumothorax.

4. Contraindication of non invasive ventilation (NIV)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP + ST	CPAP	Continuous positive airway pressure (CPAP) and Standard medical therapy (ST)
BiPAP + ST	BIPAP	Bilevel positive airway pressure (BiPAP) and standard medical therapy (ST)
ST	standard therapy (ST)	Standard Medical therapy (ST)

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Were Intubated	During ICU Stay	Number of patients who were subjected to endotracheal intubation and invasive mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
Arterial Blood Gases, Respiratory Rate, Blood Pressure, Cardiac Output ,Intrapulmonary Shunt, A-a Oxygen Gradient, Heart Rate, and Dyspnea Duration of Hospital and ICU Stay and Mortality	Hospital stay

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt